Device Risk Management and Governance (SPE303)

10 credits

Aim of this module

The aims of the rotation are to allow the trainee to gain experience of operating a wide range of medical devices and appreciation of their application in the clinical setting, and an insight into and practical experience of all elements of the medical device management life cycle, including device selection, commissioning, device maintenance, patient safety, training and condemnation. The trainee will also be introduced to the requirements for and use of a medical device information system and patient safety and device risk management. The trainee will gain an overview of the roles and responsibilities of a device risk management service and the local arrangements for service delivery and will be able to work effectively in the clinical setting assist them in choosing their future area of specialisation.

  1. Operate a wide range of medical devices used in the clinical environment, understanding their clinical applicability, associated risks and limitations.
  2. Operate standard workshop test equipment, specialist medical device test instrumentation, including electromedical safety testers. Using appropriate equipment to test a range of Class 1 and Class 2 equipment of types B, BF and CF, including some with applied parts. 
  3. Carry out the following device life cycle technical tasks:
    1. identify the key elements involved in a medical device procurement exercise
    2. acceptance test and commission a new medical device
    3. design of training material to support the use of a medical device in the clinical setting
    4. perform planned maintenance on a range of medical devices
    5. describe and observe the device repair process
    6. condemn a medical
  4. Identify sources of patient safety information and describe the key elements of processes to manage safety alerts and investigate patient incidents involving medical devices. 
  5. Identify and navigate the standards that underpin the organisations strategy for medical device management and service delivery arrangements for life cycle management including:
    1. prevailing national standards for healthcare
    2. legal/statutory requirements
    3. Electro-medical safety standards
    4. quality management standards
    5. risk management standards
    6. best practice standards
    7. organisational polices, and procedures, together with medical device workshop-specific
  6. Use the organisation’s medical device information system for device risk management activities, including the recording of key information relating to life -cycle service elements as well as the ability to retrieve essential asset-related information and reports.
  7. Perform a risk assessment on a piece of equipment or a service-related issue, showing an appreciation of local institutional risk management policies and procedures. 
Number Work-based learning outcome Title Knowledge
1 1,2

Operate a wide range of commonly encountered medical devices used in the organisation, ensuring coverage of diagnostic, monitoring and therapeutic equipment types.

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2 1,2

Electrically safety test a range of Class1 and Class 2 devices, of types B, BF and CF, including the testing of applied parts

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3 1,2

Access information sources to aid with the operation of devices, including manufacturer’s instructions for use, medical device workshop manuals, organisations medical device training resources

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4 3

Participate in the development and execution of a medical device procurement exercise

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5 3

Carry out acceptance tests, including commissioning devices into clinical use

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6 3

Medical device training:

  • Complete a competency-based training programme for a medical device
  • Shadow company representatives delivering equipment training to clinical users
  • Contribute to the delivery of training to support the use of a medical device in the clinical setting in conjunction with training officers in theorganisation
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7 3

Undertake planned maintenance on a range of medical devices and complete service records comprehensively and legibly

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8 3

Observe the process for device repair and observe medical devices being repaired

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9 3

Clean and decontaminate a medical device

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10 3

Participate in the removal of a medical device from service

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11 4

Participate in the actions on a safety alert from receipt into the organisation, through determination of actions, execution of work, monitoring of progress and closure

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12 4

Participate in the investigation of a medical device incident within the organisation

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13 5

Investigate and describe the organisational approach to medical device management and the management of the life cycle of medical devices

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14 5

Identify and navigate the standards that underpin or are used within the organisation’s medical device management strategy and associated service delivery

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15 6

Use the organisation’s medical device information system to:

  • recall inventory item details
  • log an equipment fault or service request
  • generate asset/maintenance reports, for an individual device or group of devices
  • generate key performance data
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16 7

Undertake a risk assessment on a piece of equipment or a service- related issue in accordance with ISO 14971 and local trust risk management policies and procedures

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You must complete
1 Case-based discussion(s)
1 of the following DOPS / OCEs
Assessment Title Type
Carry out a range of medical device life cycle procedures, including acceptance testing, planned maintenance, device verification and condemnation, including the use of patient simulators, test equipment and electro medical safety testers DOPS
Navigate the medical device information system, including production of simple asset detail and maintenance reports . DOPS
Access and interpret relevant medical device management standards that the healthcare institution have to work to DOPS
Complete a real or shadow change to an operating procedure used in medical device maintenance DOPS
Describe the key services of the medical device life cycle process and the prevailing standards healthcare organisations work to DOPS

Important information

The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.

Learning Outcomes

  1. Discuss and evaluate the role of Clinical Engineering in innovation and service development. 
  2. Describe the legislation that underpins safe working within the radiation, workshop and clinical environements.  

Indicative Content

Medical Device Life Cycle

  • Health Technology Assessment
  • Principles of project management
  • Quality systems and standards
    • ISO9000
    • EN13485
  • Equipment evaluation
  • Medical device life cycle
  • Medical Devices Directorate
  • Risk management principles applied to medical devices

 

Introduction to Radiation Physics

  • X-rays, electrons (betas), neutrons, alpha and other particles
  • Radioactivity units and relationships
  • X-ray production
  • Physical effects of radiation
  • Interaction processes with matter
  • Measurement and instrumentation
  • Biological effects of ionising radiation
  • Basic principles of imaging:
    • X-ray, computerised tomography (CT)
    • magnetic resonance (MR)
    • nuclear medicine
    • ultrasound (US)
  • Non-ionising radiations including ultraviolet (UV), radiofrequency (RF) and microwaves, lasers, infrared, magnetic fields and ultrasound
  • Radiation safety: dose limits; national and international organisations and recommendations; legislation; principles of protection, safe practice, monitoring and reporting applied to:
    • ionising radiation
    • UV, microwave, RF and magnetic fields, lasers and ultrasound